Researching the Effects of Sepsis on Quality Of life, Vitality, Epigenome and gene expression during RecoverY from sepsis (REQOVERY)

Completed

Conditions: sepsis
10019815

Registration Number: NL-OMON50782

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

Inclusion criteria sepsis group:
- Adult patients, aged between 18 and 85 years
- Able to provide informed consent themselves or informed consent can be
obtained via next of kin or legal guardian
- Included in Acutelines, where blood sample were was drawn within 24 hours
upon of ED admission according to Acutelines protocol
- Satisfy the Sepsis-3 criteria for sepsis (Figure 2), combined with clinical
suspicion of infection and/or fever (body temperature > 38.5°C)
- Survive at 3 months post discharge

Inclusion criteria control group: adult patients, aged between 18 and 85 years
- Able to provide informed consent themselves or informed consent can be
obtained via next of kin or legal guardian
- Included in Acutelines, where blood sample was drawn upon ED admission
- Non-infectious reason of admission, specifically syncope, electrolyte
disturbance, intoxication, gastro-intestinal bleeding, undifferentiated
complaints

Exclusion Criteria

- Transfer from another hospital
- Emergency room visit in connection with accidental exposure of bodily
material to patient (needle stick injury)
- Visit an emergency room in connection with organ transplantation
- Discharged home without hospital admittance after ED visit
- Unable to give blood
- Immunosuppressive therapies such as corticosteroids (>10mg) or small molecule
immune suppressants within the last three months, or biologicals administered
within the last year
- Radiotherapy or systemic chemotherapy within the last three months
- Known pregnancy; the presence of pregnancy will be verified by asking the
potential participant
- A hospitalization of more than 21 days

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the current project is to measure changes in DNA<br /><br>methylation (i.e. epigenetics) and gene expression (i.e. transcriptomics) of<br /><br>blood leukocytes between sepsis survivors at ED admission and three months<br /><br>after hospital discharge. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to correlate these changes with DNA methylation<br /><br>and gene expression with clinical data of sepsis survivors including<br /><br>post-sepsis syndrome symptoms (e.g. cognition, neuropsychiatric symptoms,<br /><br>quality of life), cytometric and biochemical parameters that assess organ<br /><br>function, rehospitalization frequency, and mortality, as well as the soluble<br /><br>proteome and metabolome in blood to explore regulatory mechanisms. Lastly, we<br /><br>will compare the DNA methylation and gene expression profile with the age and<br /><br>sex-matched control group.</p><br>